NCT00088764

Pain and Stress Management for People With Rheumatoid Arthritis

Disclosure and Skills Training for Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Self-management of rheumatoid arthritis (RA) symptoms using written emotional disclosure (ED), coping skills training (CST), or a combination of both may benefit people with RA. The purpose of this study is to determine the benefits of ED, CST, or CST and ED together in adults with RA. This study will be conducted at Wayne State University in Detroit, Michigan and Duke University Medical Center in Durham, North Carolina.

Detailed description

Two self-management strategies hold promise for improving the health of people with RA: ED (writing about stress, RA, and coping options) and CST (learning six pain and stress coping skills). A strategy integrating ED with CST may be more effective than either intervention alone. This study will compare the effectiveness of ED, CST, ED in combination with CST, and control groups in alleviating the symptoms of RA. This study will last until May 2009. Participants with RA will be randomly assigned to 1 of 4 treatment groups. Each participant will receive 3 writing sessions and 8 training sessions. Group 1 will receive ED writing followed by CST; Group 2 will receive ED writing followed by arthritis education; Group 3 will receive health behavior writing followed by CST; and Group 4 will receive health behavior writing followed by arthritis education. Participants will be evaluated at baseline and at Months 1, 4, and 12 for pain, physical disability, psychological impairment, and disease activity. In addition, participants will record daily diaries for 30 days regarding their pain, symptoms, coping, stress, and mood prior to each of the evaluations. Changes in health status over time will be compared among groups.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BEHAVIORAL	Coping skills training	8 sessions of pain and stress coping skills training
BEHAVIORAL	Written emotional disclosure	4 sessions of writing about stress
BEHAVIORAL	Arthritis education	8 sessions of learning about rheumatoid arthritis
BEHAVIORAL	Health behavior writing	4 sessions of writing about various health behaviors

Timeline

• Start date: 2005-02-01
• Primary completion: 2009-04-01
• Completion: 2009-06-01
• First posted: 2004-08-05
• Last updated: 2013-08-15

Locations

2 sites across 1 country: United States